We used to see the ads on TV. Your cholesterol goes out of whack because of two things: cholesterol from the food you eat, and genetic cholesterol problems. So, being the good and wise patient you were, you discussed the subject with your doctor and he or she suggested Vytorin. Why? Because it was said to battle both types of cholesterol. And that can help prevent heart attacks and strokes.
Turns out that those clever marketers at both Shering Plough and Merck — the manufacturers of the components of Vytorin — had us all fooled. Billions of dollars later (yes — I mean billions!) they announced that — oops! Vytorin not only doesn’t work to reduce cholesterol and protect us from heart attacks and strokes, but it might even cause us additional cholesterol problems, worse than we had before we took the drug!
This isn’t really new news — the results of the most recent study were actually released back in January. The point is only raised today because it became official when announced at this week’s meeting of the American College of Cardiologists. But since then, there have been a few aspects of the announcements that most patients don’t understand, or haven’t thought about. So — here’s some food for thought:
What exactly is Vytorin? It is a combination drug. Shering Plough makes one statin (cholesterol-lowering drug) called Zetia. Merck makes another one called Zocor. Their brilliant marketing minds decided to mix them together because two kinds should lower cholesterol even better than one, right? Turns out, that wasn’t always right.
If the drug doesn’t work, then how did it get FDA approval to begin with? Good question. It was approved for sale in 2004, presumably because the FDA bought the argument that the two components, both Zocor and Zetia would work in combination. Fooled the FDA! (nothing new)
Why doesn’t it work? Turns out that the bigger question being asked isn’t so much whether or not any of these statins really lower someone’s cholesterol levels; rather, the question is whether or not lowering someone’s bad cholesterol really prevents heart disease or stroke. Evidently, just because someone’s LDL (bad cholesterol) is lower doesn’t mean they are really protected.
How can that be? We’ve known for years that LDL needs to be low, and HDL should be high for protection. That’s actually what was disproved from this test — that the assumptions about LDL and HDL may be wrong!
Who is most upset at this news? The answer is probably a four way tie:
Doctors are very upset because they were fooled (and who likes to be made a fool?) How will they ever trust Merck or Shering Plough again? (OK — not sure how they trust Merck after the vioxx scam anyway?)
Insurers are very upset because they have been paying big bucks for Vytorin (when it was launched, it cost $2.34/tablet). Generic statins, which would have been more effective for patients would have cost a fraction of the price.
Investors / stockholders of both Merck and Shering Plough are hurting — their stock value has nose-dived.
And the pharmaceutical reps who work for both companies, and sell doctors on the drugs are angry — through no fault of their own, the rug has been pulled out from under their career legs. No doctor will ever prescribe Vytorin again. And anything sold by Merck or Shering Plough will be suspect.
We patients should get mad, too. We should be angry because the FDA allowed itself to be fooled and approved a drug — yet another one — that is not beneficial to patients, and can harm them, too.
What should patients do if they take Vytorin, Zetia, Zocor or any other statin? Don’t change anything until you check with your doctor. The bottom line of the study doesn’t seem to be that any of them are dangerous. Instead they just aren’t effective.
See your doctor. Ask tough questions. And partner with him or her to decide what to do next.